SEA RESULTS LINE RESOLUTION SEA RESULTS LINE RESOLUTION SPF30- avobenzone,homosalate,octisalate,oxybenzone cream 
H2O PLUS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts


Avobenzone 3.0%
Homosalate 8.0%
Octisalate 4.0%
Oxybenzone 5.0%

Sunscreen
Sunscreen
Sunscreen
Sunscreen

• Helps prevent sunburn
• If used as directed with other sun protection measures
(see directions) decreases the risk of skin cancers and early skin aging

• For external use only • Do not use on damaged or broken skin
• Stop use and ask a doctor if rash occurs

• Keep out of eyes, Rinse with water to remove. Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away

• For Sunscreen use
• Apply liberally 15 minutes before sun exposure
• Use water resistance sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: Ask a doctor

Protect the product in this container from excessive heat
and direct sun

Acetyl Hexapeptide-8, Alcohol, Aqua/Water/Eau,
Benzoic Acid, Butylene Glycol, Butylparaben,
C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl
Glucoside, Cyclopentasiloxane, Dehydroacetic
Acid, Dimethicone, Ethylhexylglycerin,
Ethylparaben, Glycerin, Glyceryl Stearate,
Himanthalia Elongata Extract, Isobutylparaben,
Linalool, Magnesium Ascorbyl Phosphate,
Methylisothiazolinone, Methylparaben,
Panthenol, Parfum/Fragrance, Phenoxyethanol,
Phospholipids, Polyaminopropyl Biguanide,
Porphyra Umbilicalis Extract, Potassium Sorbate,
Propylparaben, Retinyl Palmitate, Silica,
Solidago Virgaurea (Goldenrod) Extract,
Spirulina Maxima Extract, Tocopheryl Acetate,
Triethanolamine, Trisiloxane, Tropaeolum Majus
Flower Extract, Xanthan Gum

Image of Label Carton srlr276.jpgImage of Label Carton

SEA RESULTS LINE RESOLUTION  SEA RESULTS LINE RESOLUTION SPF30
avobenzone,homosalate,octisalate,oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-276
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mL  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate8 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate4 mL  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HIMANTHALIA ELONGATA (UNII: 21RND18XRR)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50)  
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TRIETHANOLAMINE HYDROCHLORIDE (UNII: R297UJ9QDY)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
TROPAEOLUM MAJUS (UNII: 9G6ZOS4L87)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65903-276-011 in 1 CARTON
150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2012
Labeler - H2O PLUS (807722947)

Revised: 9/2011
Document Id: 5a1f5f5e-7602-4493-a9dc-b7229f61692d
Set id: 5e1b1cb3-3f23-4b72-925d-1d0214a9c29e
Version: 1
Effective Time: 20110929
 
H2O PLUS